Quality Assurance Pharmacist

6 days ago

Pretoria, South Africa Isilumko Staffing Full time

One of our state owned clients are in need of an experienced and registered Quality Assurance Pharmacist towards Pretoria. 

Qualifications and experience:

  • B.Pharm degree or related
  • GMP training
  • Registered as a practicing pharmacist with SAPC
  • No less than 5 years' experience in a pharmaceutical manufacturing company, no less than 3 years' in a QA role

Knowledge: 

  • ISO
  • GMP
  • QA principles 

Key skills:

  • Communicate at all levels 
  • Computer literate
  • Time management
  • Planning
  • Attention to detail 

Key performance areas: 

  • Ensuring adherence to quality management system and good manufacturing practices, ISO9001
  • Authorize product releases and recording verifications
  • Managing and controlling the process for quarantine, sample and release of products for sale
  • Review and release packaging material, raw material, intermediate products and finished goods
  • Inspection of retention samples as representatives sample of batch
  • Recommending product recalls where products do not meet specifications 
  • Controlling the issuing of labels and controlled printed materials 
  • Serving as a member of the change control committee 
  • Implement and guide: NTP in QQA GMP and ISO principles 
  • Make decisions according to approved cGMP requirements, SOP's and / or corporate procedures and principles, within scope of Deputy Responsible Pharmacist
  • Ensure compliance to GMP, with specific reference to radiopharmaceutical products - process inspections
  • Prepare, update, review, approve procedures 
  • Train on cGMP and relevant SOP and related topics
  • Maintain and ensure compliance to quality agreements
  • Prepare for and participate in management review
  • Lead or partake in risk assessments and validations activities 
  • Coordinate and control the stability program
  • Preforming annual product reviews
  • Performing trend analysis of various quality parameters of products
  • Drafting monthly and quarterly reports
  • Administer continual improvement system and lead or partake in CAPA / deviation investigations
  • Establish specifications
  • Assist in conducting supplier and internal audits, preparing for audits by 3rd parties
  • Reviewing new guidelines, outside inspection reports and current trends in GMP
  • Assisting the project groups on projects, QA activities on new product development and new facilities 

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